UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032605 |
|---|---|
| Receipt number | R000037179 |
| Scientific Title | The Impact of the Sampling Rate of Dynamic Myocardial Computed Tomography Perfusion on the Quantitative Assessment of Myocardial Blood Flow |
| Date of disclosure of the study information | 2018/05/16 |
| Last modified on | 2019/05/25 10:10:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Impact of the Sampling Rate of Dynamic Myocardial Computed Tomography Perfusion on the Quantitative Assessment of Myocardial Blood Flow
Acronym
Impact of Sampling Rate on CT-MBF
Scientific Title
The Impact of the Sampling Rate of Dynamic Myocardial Computed Tomography Perfusion on the Quantitative Assessment of Myocardial Blood Flow
Scientific Title:Acronym
Impact of Sampling Rate on CT-MBF
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the influence of reducing the shot-to-shot sampling rate of dynamic myocardial computed tomography perfusion (CTP) scans on the computation of CTP-derived myocardial blood flow (CT-MBF) and diagnostic performance for detecting myocardial perfusion abnormalities.
Basic objectives2
Others
Basic objectives -Others
influence
diagnostic performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The global CTMBFs with 2RR, 3RR, and 4RR sampling are compared with that with 1RR sampling as a reference, using the equivalence test with Bonferroni correction.
Key secondary outcomes
The Pearson rank correlation test is used to assess the relationship between the global CTMBF with 1RR sampling and that with 2RR, 3RR, or 4RR sampling. The equivalence test with Bonferroni correction is used to compare segmental CT-MBFs with 2RR, 3RR, and 4RR sampling to that with 1RR sampling for normal and abnormal myocardial segments that were assessed with cardiac MR. The areas under the receiver operating characteristic curve of segmental CT-MBF with 2RR, 3RR, and 4RR sampling are compared with that with 1RR sampling.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent stress dynamic CTP for the assessment of CAD between July 2013 and November 2017.
Key exclusion criteria
(1) acute myocardial infarction (<30 days from the onset), (2) cardiomyopathy, (3) left ventricular ejection fraction <20%, (4) atrial fibrillation, (5) an atrioventricular block greater than the first degree, (6) complete left bundle branch block, (7) history of percutaneous coronary intervention or coronary artery bypass grafting, (8) poor cardiac MR image quality, and (9) an inappropriate CTP dataset such as that with insufficient image quality, misaligned scan coverage, and delayed data acquisition of dynamic CTP causing a shorter baseline (before upslope) of the TAC in the ascending aorta.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Takahrio |
| Middle name | |
| Last name | Yokoi |
Organization
Ehime University Graduate School of Medicine
Division name
Radiology
Zip code
7910295
Address
Shitsukawa, Toon, Ehime, Japan
TEL
+81-89-960-5371
mr.taka451@gmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yokoi |
Organization
Ehime University Graduate School of Medicine
Division name
Radiology
Zip code
7910295
Address
Shitsukawa, Toon, Ehime, Japan
TEL
+81-89-960-5371
Homepage URL
mr.taka451@gmail.com
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ehime University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University Graduate School of Medicine
Address
Shitsukawa, Toon , Ehime
Tel
0899605371
mr.taka451@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
120
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective
Management information
Registered date
| 2018 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037179
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
